CDC Advisory Panel Recommends Merck’s RSV Shot for Infants

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend Merck’s new monoclonal antibody shot, clesrovimab (previously referred to as Enflonsia), for infants aged 8 months or younger during their first respiratory syncytial virus (RSV) season. This decision marks a significant step forward in protecting vulnerable infants from serious RSV-related illnesses.

Background on RSV and Its Impact on Infants

RSV is a highly contagious virus that affects people of all ages but is most severe in young children and older adults. Infants are particularly at risk, with RSV being a leading cause of hospitalization in this age group. Currently, the CDC recommends RSV vaccines for pregnant women between 32 and 36 weeks of pregnancy to provide protection to newborns during their first RSV season. However, not all infants are protected through maternal vaccination, highlighting the need for alternative preventive measures.

The New Merck RSV Shot

Merck’s clesrovimab is designed to provide direct protection against RSV for infants who may not have received sufficient protection through maternal vaccination. The shot is administered as a single dose and is intended for infants aged 8 months or younger during their first RSV season. The ACIP’s recommendation is based on clinical trial data demonstrating the safety and efficacy of clesrovimab in preventing serious RSV disease in infants.

The ACIP Vote and Its Implications

The ACIP vote was not unanimous, with two committee members opposing the recommendation due to concerns about safety. Despite this, the 5-2 vote in favor of recommending clesrovimab marks an important milestone in the effort to protect infants from RSV. The CDC is expected to review the ACIP’s recommendation and make a final decision on the use of clesrovimab in the coming weeks.

The introduction of clesrovimab as a preventive measure against RSV could significantly reduce the number of hospitalizations and serious illnesses caused by the virus in infants. This is particularly important for infants who are at high risk of severe RSV disease due to underlying health conditions or other factors.

Future Outlook and Potential Impact

The approval of Merck’s clesrovimab would provide an additional tool in the fight against RSV, complementing existing preventive measures such as maternal vaccination. As RSV continues to be a significant public health concern, the availability of effective preventive therapies is crucial. The CDC’s final decision on clesrovimab will be closely watched, as it has the potential to impact RSV prevention strategies for the upcoming RSV season.

Key Takeaways

• The CDC’s ACIP has voted to recommend Merck’s new RSV antibody shot, clesrovimab, for infants aged 8 months or younger during their first RSV season.
• The recommendation is based on clinical trial data demonstrating the safety and efficacy of clesrovimab in preventing serious RSV disease.
• The vote was not unanimous, with two committee members opposing the recommendation due to safety concerns.
• The CDC is expected to review the ACIP’s recommendation and make a final decision on the use of clesrovimab.
• The introduction of clesrovimab could significantly reduce RSV-related hospitalizations and serious illnesses in infants.